# K201382: X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)

- Pathway: 510(k) (Abbreviated)
- Applicant: De Gotzen S.R.L.
- Decided: Nov 18, 2020 after 176 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K973598 (1997). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180601: Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology), Villa Sistemi Medicali S.P.A. (2018) Summary page 5.
- K181297: DENTIOIII series (DENTIOIII, DENTIOIII-S), Hdx Will Corp. (2018) Summary page 6.

## Indications for use
X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the bone growth. Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped X-ray beam technique; both of them are well known techniques. The device is operated and used by dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D). The target patient population includes adults and pediatric patients from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.

Source page: https://510kreport.com/device/K201382
Methodology: https://510kreport.com/methodology